Summary of Product Characteristics (SmPC) - Vesagex Antiseptic cream
1 NAME OF THE MEDICINAL PRODUCT
Vesagex Antiseptic Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide BP 1.0% w/w
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
A White opaque cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an antiseptic cream for cuts and abrasions, minor skin disorders, dry and cracked skin, minor burns and nappy rash.
4.2 Posology and method of administration
For external use only
For all ages and all listed indications; apply liberally as required First aid: gently wash and dry the affected area, then apply the cream to soothe and help prevent infection.
Nappy rash: when changing the nappy, gently wash and dry the baby’s skin and then apply the cream.
4.3 Contraindications
For cutaneous use only
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Prolonged and repeated applications of cetrimide to the skin may lead to hypersensitivity. Avoid contact with eyes. For external use only; not for use in body orifices.
Antiseptic First Aid Cream contains the excipients cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions.
Label to state: FOR EXTERNAL USE ONLY.
Keep out of the sight and reach of children
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
No information is available on the safety or use of the product in the above conditions
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Skin irritation and occasionally sensitization.
Hypersensitivity may occur, presenting as localized contact dermatitis. Excessive dryness of the skin may occur in patients who become hypersensitive to cetrimide. Discontinue use (See section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Overdose by the recommended route of administration is considered unlikely. Ingestion may cause nausea and vomiting. Toxic symptoms include dyspnoea and cyanosis, possibly leading to asphyxia. Depression of the central nervous system, hypotension and coma may also occur.
Treatment of poisoning is symptomatic. Demulcents and diluents may be given if necessary but emesis and lavage should be avoided. Activated charcoal may be considered if the patient presents within an hour of indigestion
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
D08A J04 – antiseptics and disinfectants, quaternary ammonium compounds
Cetrimide is a quaternary ammonium disinfectant with properties and uses typical of cationic surfactants. These surfactants dissociate in aqueous solution into a relatively large and complex cation, which is responsible for the surface activity, and a smaller inactive cation. It has bactericidal activity against Gram-positive and, at higher concentrations, against some Gram-negative organisms.
Cetrimide is relatively ineffective against viruses.
5.2 Pharmacokinetic properties
Vesagex Antiseptic Cream is intended for cutaneous use only.
5.3 Preclinical safety data
No data of relevance which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Chlorocresol
Liquid Paraffin
Cetostearyl alcohol
Glycerol
Verbena Oil
Purified Water
6.2 Incompatibilities
Not applicable, cutaneous preparation.
Cetrimide is incompatible with soaps and other anionic surfactants, Bentonite, Iodine, Phenylmercuric Nitrate and Alkali Hydroxides.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
White Plastic Tubs Pack size 500g Aluminium tubes pack size 15g, 30g and 60g Not all packed sizes may be marketed
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Key House
Sarum Hill, Basingstoke
RG21 8SR
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0967
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/07/2006
10 DATE OF REVISION OF THE TEXT
12/09/2024